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Adverse Events in Patients Taking Cephalosporins Versus Placebo for Any Indication

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Adverse Events in Patients Taking Cephalosporins Versus Placebo for Any Indication Bond University Research Repository Adverse events in patients taking cephalosporins versus placebo for any indication Mccullough, Amanda; Scott, Anna M.; Macindoe, Christopher; Clark, Justin; Hansen, Malene Plejdrup; Beller, Elaine M.; Aronson, Jeffrey K.; Del Mar, Chris B. Published in: Cochrane Database of Systematic Reviews DOI: 10.1002/14651858.CD012435 Licence: Other Link to output in Bond University research repository. Recommended citation(APA): Mccullough, A., Scott, A. M., Macindoe, C., Clark, J., Hansen, M. P., Beller, E. M., Aronson, J. K., & Del Mar, C. B. (2016). Adverse events in patients taking cephalosporins versus placebo for any indication. Cochrane Database of Systematic Reviews, 2016(11), 1-10. [CD012435]. https://doi.org/10.1002/14651858.CD012435 General rights Copyright and moral rights for the publications made accessible in the public portal are retained by the authors and/or other copyright owners and it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights. For more information, or if you believe that this document breaches copyright, please contact the Bond University research repository coordinator. Download date: 27 Sep 2021 Cochrane Database of Systematic Reviews Adverse events in patients taking cephalosporins versus placebo for any indication (Protocol) McCullough A, Scott AM, Macindoe C, Clark J, Hansen MP, Beller EM, Aronson JK, Del Mar CB McCullough A, Scott AM, Macindoe C, Clark J, Hansen MP, Beller EM, Aronson JK, Del Mar CB. Adverse events in patients taking cephalosporins versus placebo for any indication. Cochrane Database of Systematic Reviews 2016, Issue 11. Art. No.: CD012435. DOI: 10.1002/14651858.CD012435. www.cochranelibrary.com Adverse events in patients taking cephalosporins versus placebo for any indication (Protocol) Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 BACKGROUND .................................... 1 OBJECTIVES ..................................... 2 METHODS ...................................... 2 ACKNOWLEDGEMENTS . 5 REFERENCES ..................................... 5 APPENDICES ..................................... 6 CONTRIBUTIONSOFAUTHORS . 9 DECLARATIONSOFINTEREST . 9 SOURCESOFSUPPORT . 9 Adverse events in patients taking cephalosporins versus placebo for any indication (Protocol) i Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Protocol] Adverse events in patients taking cephalosporins versus placebo for any indication Amanda McCullough1, Anna M Scott1, Christopher Macindoe2, Justin Clark1, Malene Plejdrup Hansen3,4, Elaine M Beller1, Jeffrey K Aronson5, Chris B Del Mar1 1Centre for Research in Evidence-Based Practice (CREBP), Bond University, Gold Coast, Australia. 2Gold Coast University Hospital, Southport, Australia. 3Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark. 4Research Unit for General Practice in Aalborg and Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. 5Clinical Pharmacology, Oxford University, Oxford, UK Contact address: Amanda McCullough, Centre for Research in Evidence-Based Practice (CREBP), Bond University, Gold Coast, Queensland, Australia. [email protected]. Editorial group: Cochrane Acute Respiratory Infections Group. Publication status and date: New, published in Issue 11, 2016. Citation: McCullough A, Scott AM, Macindoe C, Clark J, Hansen MP, Beller EM, Aronson JK, Del Mar CB. Adverse events in patients taking cephalosporins versus placebo for any indication. Cochrane Database of Systematic Reviews 2016, Issue 11. Art. No.: CD012435. DOI: 10.1002/14651858.CD012435. Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. ABSTRACT This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To quantify the incidence of any reported adverse event in patients taking cephalosporins compared with placebo for any indication. Description of the intervention BACKGROUND Cephalosporins are a subclass of the β-lactams. The list of Inter- national Nonproprietary Names, compiled by the World Health Organization (WHO), contains 80 cephalosporins (WHO 2016), all of which share a common β-lactam ring and have medium to Description of the condition broad spectrum activity against both Gram-positive and Gram- negative bacterial species (Rang 2015), including Pseudomonas Use of cephalosporin antibiotics (known as cephalosporins) varies, aeruginosa (P aeruginosa), Streptococcus pneumoniae (S pneumo- with usage as low as 0.2% in Denmark and as high as 23.5% in niae), Staphylococcus aureus (S aureus), Haemophilus influenzae (H Malta (ECDC 2014). Variations in cephalosporin use may be due influenzae), Klebsiella pneumoniae (K pneumoniae), and Escherichia to concerns about the development of antibiotic resistance. Indica- coli (E coli)(Therapeutic Guidelines 2014). Cephalosporins are tions include: respiratory tract infections (acute otitis media, bac- often referred to as first, second, or third generation, based on the terial sinusitis, severe pneumonia), bacterial meningitis, urinary order in which they were developed. tract infections, septicaemia, surgical prophylaxis, skin and soft tis- An adverse event is an adverse outcome that occurs while a patient sue infections, and gonorrhoea (Australian Medicines Handbook is taking a drug, but the event is not (or not necessarily) attributable 2015). Adverse events in patients taking cephalosporins versus placebo for any indication (Protocol) 1 Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. to the drug taken (Edwards 2000). Adverse events in those taking antibiotics are usually measured by It has been recommended that the recording of adverse events observational mechanisms: anecdotal reporting; voluntary organ- in clinical trials should distinguish suspected adverse effects from ised reporting; intensive event monitoring; and observational re- suspected adverse reactions (Aronson 2013), defined as follows. search studies (Edwards 2000). These approaches are susceptible 1. Adverse effects are unwanted outcomes of which the patient to reporting biases (Edwards 2000); and misclassification of the is not aware; they are usually detected by laboratory tests (e.g. cause of events which could be due to the antibiotic or the under- biochemical, haematological, immunological, radiological, lying disease for which it was prescribed. Randomised controlled pathological tests) or by clinical investigations (e.g. trials (RCTs) of antibiotics, the gold standard for determining ef- gastrointestinal endoscopy, cardiac catheterisation). ficacy of interventions, are often underpowered to detect differ- 2. Adverse reactions are unwanted outcomes that the patient ences in adverse events (Chen 2014). Several systematic reviews of experiences and are detected by their clinical manifestations RCTs in the Cochrane Library have reported on adverse events in (symptoms and/or signs). those taking cephalosporins (Kilburn 2010; Paul 2010), but noted 3. Serious adverse events are often reported separately. These that there were insufficient data on adverse events to make clear are adverse events that occur at any dose, and result in death or conclusions (Kilburn 2010). One way of overcoming this problem life-threatening events; requirement for hospitalisation or is to carry out a ‘multi-indication’ review i.e. a review of the effects prolongation of existing hospitalisation; persistent or significant of an intervention in all participants using the intervention for disability; or congenital anomalies; or are events that are any reason (indication). This type of review is particularly useful considered medically important (ICH 2003). for detecting rare events like adverse events, where the mechanism Recent guidance suggests that clinical trial authors should report of action is unrelated to the indication (Chen 2014). This review all adverse events that occur in more than 5% of any group (Zarin is the third in a series of multi-indication reviews investigating 2016). The events can be classified by the 27 System Organ Classes adverse events in those taking antibiotics (Gillies 2015; Plejdrup (e.g. blood and lymphatic system disorders) defined by the Medical Hansen 2015). Dictionary for Regulatory Activities (MedDRA) or the 335 High Level Group Terms of this classification (MedDRA 2016). OBJECTIVES How the intervention might work Antibiotics can cause unwanted events in different ways. To quantify the incidence of any reported adverse event in patients 1. Hypersensitivity reactions, in which the host generates an taking cephalosporins compared with placebo for any indication. immune response to the drug, perhaps manifesting as a rash (Ibia 2000), and which can occur even at doses that are below the usual therapeutic range. METHODS 2. Adverse reactions that occur at doses in the usual therapeutic range (called collateral reactions). Some of these can occur through direct adverse effects (e.g. nausea and vomiting due to altered gastric emptying; Kuo 1998); and others through Criteria for considering studies for this review destruction of commensals (disturbing the equilibrium of the microbiome, which might cause diarrhoea from an overgrowth of Clostridium difficile (C difficile);
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